Primary Device ID | G507ZOICX05000 |
NIH Device Record Key | be71f5ea-1954-40e7-a635-2ef03aad52fe |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ZOICX™ |
Version Model Number | ZOICX0500 |
Catalog Number | ZOICX0500 |
Company DUNS | 965420953 |
Company Name | Incell Corporation, LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 800-364-1765 |
info@incell.com | |
Phone | 800-364-1765 |
info@incell.com | |
Phone | 800-364-1765 |
info@incell.com | |
Phone | 800-364-1765 |
info@incell.com | |
Phone | 800-364-1765 |
info@incell.com | |
Phone | 800-364-1765 |
info@incell.com | |
Phone | 800-364-1765 |
info@incell.com | |
Phone | 800-364-1765 |
info@incell.com | |
Phone | 800-364-1765 |
info@incell.com | |
Phone | 800-364-1765 |
info@incell.com | |
Phone | 800-364-1765 |
info@incell.com | |
Phone | 800-364-1765 |
info@incell.com | |
Phone | 800-364-1765 |
info@incell.com | |
Phone | 800-364-1765 |
info@incell.com | |
Phone | 800-364-1765 |
info@incell.com | |
Phone | 800-364-1765 |
info@incell.com | |
Phone | 800-364-1765 |
info@incell.com | |
Phone | 800-364-1765 |
info@incell.com |
Total Volume | 500 Milliliter |
Total Volume | 500 Milliliter |
Total Volume | 500 Milliliter |
Total Volume | 500 Milliliter |
Total Volume | 500 Milliliter |
Total Volume | 500 Milliliter |
Total Volume | 500 Milliliter |
Total Volume | 500 Milliliter |
Total Volume | 500 Milliliter |
Total Volume | 500 Milliliter |
Total Volume | 500 Milliliter |
Total Volume | 500 Milliliter |
Total Volume | 500 Milliliter |
Total Volume | 500 Milliliter |
Total Volume | 500 Milliliter |
Total Volume | 500 Milliliter |
Total Volume | 500 Milliliter |
Total Volume | 500 Milliliter |
Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | G507ZOICX05000 [Primary] |
KIT | Media And Components, Synthetic Cell And Tissue Culture |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-09-11 |
Device Publish Date | 2023-09-01 |
G507ZEFR01000 - ZEFR™ | 2023-10-10 Chemically Defined Secretome Collection Media |
G507EZNDHS05000 - EZ-CPZ-ND+2% Hetastarch (Hs)™ | 2023-09-15 Donor-organ/tissue/cell preservation solution |
G507ZAPR01000 - ZAPR™ | 2023-09-14 Red Blood Cell Lysing Buffer |
G507ZAPR04000 - ZAPR™ | 2023-09-14 Red Blood Cell Lysing Buffer |
G507ZSOLF05000 - ZSol:F™ | 2023-09-14 Bioprocessing Phosphate Buffer without Ca+2 and Mg+2 |
G507EZCZ01000 - EZ-CPZ™ | 2023-09-11 High Performance Cryopreservation Media and Storage Solution |
G507EZCZ05000 - EZ-CPZ™ | 2023-09-11 High Performance Cryopreservation Media and Storage Solution |
G507EZND01000 - EZ-CPZ-ND™ | 2023-09-11 High Performance Cryopreservation Media and Storage Solution without DMSO |